BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 300 IMAGING TABLE

    MDR report key: 9842813 · Received March 17, 2020

    Report

    Report Number
    2529571-2020-00002
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    October 12, 2015
    Report Date
    March 2, 2020
    Manufacturer
    OAKWORKS, INC.
    Product Code
    IXR
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL PROCESS AUDIT FINDING CREATED A TASK FOR PAR #5 (PREVENTATIVE ACTION RECOMMENDATION) FROM CAPA (B)(4) TO REVIEW THE COMPLAINT DATA AND RETROSPECTIVELY REPORT ANY PREVIOUSLY UNREPORTED COMPLAINTS ASSOCIATED WITH FIELD ACTION RECALL #Z-0703-2018. FOUR COMPLAINTS WERE FOUND DURING THE REVIEW THAT MEET THE CRITERIA WHICH ARE BEING REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE UP BUTTON ON THE FOOT CONTROL IS STICKING AND CAUSING THE TABLE TO CONTINUE TO RAISE AFTER THEY RELEASE THE BUTTON. CUSTOMER HAD DAMAGED THE FOOT CONTROL BY LOWERING THE COLUMN ONTO IT. NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305219 OAKWORKS MEDICAL CFPM 300 IMAGING TABLE IMAGING TABLE IXR OAKWORKS, INC. CFPM 300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1